MSB 2022 - The road to commercialisation, page-470

Unless "Whytee" works at the FDA, there's no way for him to make statements like, "The FDA rejected this approach" and "According to the FDA the reason this misunderstanding occurred...", etc. The FDA doesn't make public pronouncements like that. According to the leading experts in GvHD there's a shift going on in how children with the illness are stratified. They are all given 7 days of steroids and then two inflammatory biomarkers are checked. If the combined results of those two biomarkers are above a threshold value, they predict a mortality rate of 90%. In other words, the highest risk patients can now be identified and separated out with laboratory tests. And analysis of rem-L data for children "closely matched" to the 90% group, shows that mortality rated can be dropped to 36%. It's detailed in the company's October 17, 2021 PR and in the journal review article by Kasikis et al detailing work being done at Mt Sinai. That's why Dr. Kurtzberg and leading experts in the field are not willing to subject children to a placebo controlled trial. For every 100 children with those high-risk parameters of severe illness, a placebo sentences (90-36=) 54 of them to certain death. That's over half. This one should be a "no-brainer" for the FDA once the "well-established" resolution process eventually plays itself out

Aloha.